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Based on observation, interview, and document review, the facility failed to ensure the facility followed the state and federal Patient's Bills of Rights for 1 of 1 patient (P1) who had a civil commitment to the critical access hospital (CAH).

Findings include:

The admission history and physical dated 5/20/16, indicated P1 was admitted to the CAH on 5/20/16, with diagnoses that included: suicidal ideation. The past medical history indicated P1 had chemical dependency issues, anxiety, depression, chronic pain, diabetes, and a left below the knee amputation.

Registered nurse (RN)-E was interviewed on 6/6/16, at 3:35 p.m. and stated P1 was a patient on a hold for his safety and could not leave his room, have personal clothing, or have visitors.

RN-G was interviewed on 6/7/16, at 1:15 p.m. and stated she was going to provide P1 with a dressing change. RN-G stated that P1 had to stay in his room at all times and could not wear personal clothes for fear P1 would attempt to elope from the facility. Additionally RN-G stated that P1 could not have any visitors because he used street drugs brought in by a visitor.

P1 was interviewed on 6/7/16, at 1:20 p.m. and stated he felt he was not being treated with respect and dignity. P1 started crying and stated that his birthday was two days ago and he was not allowed out of his room or to have visitors. He stated as a result, he felt more depressed and anxious. P1 stated that he felt the hospital was worse than living in jail because he didn't have any rights to do anything or go anywhere. P1 stated it bothered him to be unable to wear personal clothing. He stated all of his clothing and belongings had been removed from his room. P1's room was observed and contained no personal belongings. P1 indicated RN-F, the discharge planning coordinator, had been the person who directed staff to remove all personal belongings, deny visitors, and restrict P1 to his room.

The facility provided the pamphlet on patient rights provided to all patients at the time of admission and the following was identified: The Minnesota State Patient's Bill of Rights dated 7/1/14, "Patients may retain and use their personal clothing and possessions as space permits, unless to do so would infringe upon rights of other patients, and unless medically or programmatically contraindicated for documented medical, safety, or programmatic reason's." The Federal Rights included: "Patients have the right to:..be free from restraints and seclusion of any form used as a means of coercion, discipline, convenience, or retaliation by staff."

Review of the physician orders revealed there was no order for P1's seclusion, visitor restrictions, or restriction of personal belongings.

The care plan for P1 last updated 6/7/16, had not identified any restriction of rights including not allowing P1 access to his personal belongings or secluding P1 to his room. Additionally, the care plan had not addressed P1's restriction from visitors.

The discharge planning coordinator RN-F was interviewed on 6/8/16, at 11:00 a.m. and stated P 1 was admitted to the facility on a 72 hold for suicidal ideation. RN-F stated P1 was a very familiar patient to the CAH and had a long history of chemical dependency and medical non-compliance. P1's primary physician felt P1 was a danger to himself. RN-F stated the hospital initiated a civil commitment process and petitioned the court due to P1's mental health and chemical dependency needs. RN-F provided a copy of the petition dated 5/25/16, and also a copy of the preliminary hearing findings dated 5/27/16, which identified P1 had waived his right to a hearing and would remain in the hospital. RN-F stated on 6/6/16, P1 had a hearing in Mille Lacs county District court and provided a Handwritten Order dated 6/6/16, which identified P1 was an "Involuntary patient at Mille Lacs Health System treatment facility. Other: Commit to Commissioner of Human Services up to 6 mos. [months]" RN-F stated she was planning on finding P1 an appropriate placement to work with his chemical dependency needs.

The director of nursing and discharge planning coordinator RN-F were both interviewed on 6/8/16, at 11:30 a.m. and both confirmed that a care conference had not been held with the interdisciplinary team to discuss the rights and visitor restrictions P1 had in place. They confirmed they had not thought about allowing P1 supervised visitation or time out of his room. They confirmed the physician had not ordered seclusion, no visitors, or no personal belongings, and a care plan had not been developed to include the restrictions. They confirmed a licensed social worker had not been consulted to work with P1, related to a lack of socialization, anxiety, and depression. They also confirmed they did not have a plan with physical therapy or therapeutic recreation for P1 to have any planned time out or away from his room. They indicated there should have been a care conference for P1 to discuss the imposed rights restrictions. The facility should have developed a plan for how to safely allow P1 socialization/visitors, time out of his room, and access to personal belongings.

Based on observation, interview, and record review the critical access hospital (CAH) was found to be out of compliance with Life Safety Code requirements. These findings have the potential to affect all patients in the hospital.
Findings include:

Please refer to Life Safety Code inspection tags: K25, and K56.

Based on observation, interview, and document review, the critical access hospital (CAH) failed to ensure intravenous (IV) solutions were stored in the emergency department's (ED) warming cabinet according to manufacturer's guidelines. This had the potential to affect all patients who were treated at the CAH's ED.
Findings include:
On 6/7/16, at 3:06 p.m. there was observed within the ED a two compartment warming cabinet. Taped to the door of the warming cabinet was a sign which informed staff that the IV fluids could only be kept in the warmer for two weeks. Blankets were stored in the lower compartment with a temperature reading for this compartment of 135 degrees Fahrenheit (F). The temperature on the upper compartment of the warming cabinet was set at 102 degrees F. Within this upper compartment, there was observed two 1000 milliliter (ml) bags of lactated ringers (LR) IV solutions in clear plastic covered pouches. Written on the outside of the clear plastic pouches for these two LR IV solutions was the date of 6/4/16.
On 6/7/16, at 3:06 p.m. registered nurse (RN)-C confirmed the date written on the plastic pouch of the IV solutions was the date they should have been removed from the warming cabinet. RN-C verified the two LR IV solutions should have been removed and replaced from the warming cabinet on 6/4/16.
On 6/7/16, at 4:10 p.m. the chief operating officer (COO) confirmed the manufacturer guidelines indicated IV solutions could be kept in the warming cabinet for up to two weeks. The COO stated a warming cabinet policy for the ED had been newly created.
The Baxter Healthcare Corporation guidelines dated 6/7/16, indicated IV solutions of volumes of 150 ml or greater could be warmed in their plastic over pouches to temperatures not to exceed 104 degrees F, and for a period no longer than 14 days.

Based on observation and interview the Critical Access Hospital (CAH) failed to ensure clean patient care equipment was stored in a clean environment.

Findings Include:

On 6/8/16, at 3:20 p.m. a tour of the soiled utility room in the acute inpatient care unit was completed with the CAH Infection Control Officer (ICO). The tour revealed an "L" shaped room which held five vital signs machines plugged into the wall. The soiled utility room also held a hopper (a large sink which is used to rinse soiled items) which was positioned approximately four feet from the vital signs machines. A large 50 gallon shredding bin was positioned between the vital signs machines and the hopper. The soiled utility room also had a counter which held a sink in the middle of the counter. On the left side of the sink the counter held 4 unopened boxes of gloves.

On 6/9/16, at 8:35 a.m. the ICO confirmed the soiled utility room held both clean and soiled items. The ICO stated the left side of the sink was considered dirty and the right side of the sink was considered clean. The ICO stated the CAH staff would bring in soiled items and use the room to rinse and/or sanitize items for future use. The ICO confirmed the vital sign machines had to potential to become soiled if staff were to use the hopper to rinse soiled items. The ICO stated there was no other area on the inpatient unit to store the clean vital sign machines which needed to be plugged into an outlet to charge. The ICO stated she had concerns about keeping the vital sign machines in the soiled utility room but didn't know where else to keep them.

A policy was requested for the storage of clean patient use equipment, one was not provided.

Based on observation, interview, and document review, the facility failed to ensure a comprehensive care plan had been developed to include federal and state patient rights restrictions and restriction of visitors for 1 of 1 patient (P1) on a civil commitment to the critical access hospital (CAH).

Findings include:

The admission history and physical dated 5/20/16, indicated P1 was admitted to the CAH on 5/20/16, with diagnoses that included suicidal ideation. The past medical history indicated P1 had chemical dependency issues, anxiety, depression, chronic pain, diabetes, and an left below the knee amputation.

Registered nurse (RN)-E was interviewed on 6/6/16, at 3:35 p.m. and stated that P1 was a patient on a hold for safety and could not leave his room, or have personal clothing or visitors.

RN-G was interviewed on 6/7/16, at 1:15 p.m. and stated she was going to provide P1 with a dressing change. RN-G stated that P1 had to stay in his room at all times and could not wear personal clothes for fear P1 would attempt to elope from the facility. Additionally RN-G stated that P1 could not have any visitors because he used street drugs brought in by a visitor.

P1 was interviewed on 6/7/16, at 1:20 p.m. and stated he felt he was not being treated with respect and dignity. P1 stated his birthday was 2 days ago and he was not allowed visitors or to be out of his room. P1 stated that he felt like the hospital was worse than living in jail. He was not able to wear personal clothing and all of his clothing and belongings had been removed from his room. P1's room was observed to be without personal belongings.

Review of the physician orders revealed there was no order for P1's seclusion, visitor restrictions, or restriction of personal belongings.

The care plan for P1 last updated 6/7/16, had not identified any restriction of rights including not allowing P1 access to his personal belongings or secluding P1 to his room. Additionally, the care plan had not addressed P1's restriction from visitors.

The discharge planning coordinator RN-F was interviewed on 6/8/16 at 11:00 a.m. and stated on 6/6/16, P1 had a hearing in Mille Lacs county District court and provided a Handwritten Order dated 6/6/16, which identified P1 was "Involuntary patient at Mille Lacs Health System treatment facility. Other: Commit to Commissioner of Human Services up to 6 mos. [months]"

The director of nursing and discharge planning coordinator RN-F were both interviewed on 6/8/16, at 11:30 a.m. and both confirmed that a care conference had not been held with the interdisciplinary team to discuss the rights and visitor restrictions P1 had in place. They confirmed they had not thought about allowing P1 supervised visitation or time out of his room. They confirmed the physician had not ordered seclusion, no visitors, or no personal belongings, and a care plan had not been developed to include the restrictions. They confirmed a licensed social worker had not been consulted to work with P1, related to a lack of socialization, anxiety, and depression. They also confirmed they did not have a plan with physical therapy or therapeutic recreation for P1 to have any planned time out or away from his room. They indicated there should have been a care conference for P1 to discuss the imposed rights restrictions. The facility should have developed a plan for how to safely allow P1 socialization/visitors, time out of his room, and access to personal belongings.

Based on document review and interview, the critical access hospital (CAH) failed to ensure each medical entry was properly authenticated with a timed and dated signature for 4 of 6 surgical outpatient records (P24, P26, P27, P28) reviewed.

Findings include:

P24 was admitted to the CAH on 4/25/16, for bilateral tympanostomy and insertion of ventilation ear tubes. The Informed Consent dated 4/25/16, lacked a time of the physician's signature.

P26 was admitted to the CAH on 4/20/16, for a scope of P26's right knee for a right medial meniscus tear. The Pre-Op, Same Day Surgery form, and the Orthopedic, Pre & Post-Op form both dated 4/20/16, and P26's Informed Consent dated 4/13/16, all lacked a time of the physician's signature.

P27 was admitted to the CAH on 6/8/16, for an open reduction internal fixation (ORIF) of a left distal radius (repair of a wrist fracture). The Pre-Op, Same Day Surgery form, and the Orthopedic, Pre & Post-Op form both dated 6/8/16, and P27's Informed Consent dated 6/1/16, all lacked a time of the physician's signature.

P28 was admitted to the CAH on 4/19/16, for a tubal ligation. The Pre-Op, Same Day Surgery form, Laparoscopic Surgery Post-Op order form, and P28's Informed Consent all dated 4/19/16, lacked a time of the physician's signature.

On 6/9/16, at 10:34 a.m. registered nurse (RN)-D, surgical services director, confirmed all orders, consents, and physician entries into the medical record should be timed and dated.
RN-D verified P24, P26, P27 and P28's medical records lacked the timing of physician orders and consents as noted above.

On 6/9/16, at 11:30 a.m. the health information manager (HIM) stated the expectation was for all surgeons to sign, date and time, their physician orders, consents and all aspects of the medical record.

Surgical Records policy dated 6/15, indicated surgical records required specific information as defined in the medical staff bylaws.

The CAH's Rules and Regulations of the Medical Staff last revised 2012, indicated in section D. Medical Records, bullet point numbered 8, "All clinical entries in the medical record must be legible. Time and date are to be indicated and all entries must be authenticated by the responsible party by written or by electronic signature."

Based on interview and document review, the critical access hospital (CAH) failed to ensure quality assurance/performance improvement (QAPI) projects were current, comprehensive and incorporated into the CAH's QAPI program for the following departments: ambulance services, anesthesia, dietary and nursing services. This had the potential to affect all patients receiving services from the CAH.

Findings include:

Ambulance Services:

On 6/6/16, at 3:30 p.m. the chief operating officer (COO) confirmed ambulance services were considered a department of the CAH.

On 6/9/16, at 9:58 a.m. quality manger (QM) confirmed ambulance services had not been reporting QAPI projects to the quality committee. The QM was unaware of any QAPI projects or initiatives conducted by the ambulance services. The emergency department/ambulance services manager was unavailable for comment. The QM confirmed each department was to report to the quality committee on a quarterly basis.

The CAH's Quality Committee meeting minutes dated 8/17/15, 11/16/15, 2/15/16, and 5/16/16, hadn't included identified QA initiatives for anesthesia and ambulance services.

A Quality Management Program policy dated 9/15, indicated each service area needed to identify one or more major monitoring and evaluation activities in their annual Service Area Quality Management Plan. Each service area was responsible for identifying opportunities to improve processes within their own area or between service area and those of other areas. In addition, the CAH identified the Plan Do Check Act methodology for undertaking performance improvement. This methodology identified potential improvements, or indicated the need for more focused review of the issues involved. It also allowed for checking the results of the improvement after implementation to ensure it produced the intended results.


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Anesthesia:

On 6/8/16, at 11:03 a.m. Certified Registered Nurse Anesthetist (CRNA)-A stated the anesthesia department had one current project for QAPI regarding ensuring post-anesthesia assessments were completed and entered into patient medical records in a timely manner. CRNA-A stated the current QAPI project had been in place since 2013. CRNA-A verified the anesthesia department did not have a current/ongoing QAPI program. CRNA-A also verified the anesthesia department QAPI was not implemented in the hospital wide QAPI program.

On 6/9/16, at 9:49 a.m. the quality manager (QM) verified the anesthesia department QAPI program was not integrated into the CAH's quality program.

Dietary:

On 6/9/16, at 9:10 a.m. the registered dietician (RD) stated she had one current project for the CAH QAPI regarding holding temperatures of foods on the steam tables. The RD stated she had been working on the project for the last 18 months. The RD verified the facility did not have a current/ongoing QAPI program for dietary.

On 6/9/16, at 9:50 a.m. quality manager (QM) verified the dietary department QAPI program was not integrated into the CAH's quality program.

Based on interview, and document review, the critical access hospital (CAH) failed to ensure peer review was conducted according to CAH policy and medical staff bylaws for 2 of 2 medical doctors (MD-B, MD-C) randomly reviewed for the peer review process.
Findings include:
MD-B received a letter dated 1/9/15, from the CAH, which notified MD-B that he had been granted provisional privileges for surgery under the category of an active staff member. The privilege period granted was 1/15/15, through 7/14/15. On 7/9/15, MD-B received another letter which indicated MD-B had been granted privileges for surgery under the category of an active staff member. The privilege period granted was 7/15/15, through 7/14/17. The privileges granted were subject to all the terms and conditions of the medical staff bylaws, rules and regulations, and CAH policies.
MD-C received a letter dated 7/2/09, from the CAH, which notified MD-C that she had been granted provisional privileges for orthopedics under the category of a courtesy staff member. The privilege period granted was 8/6/09, through 2/5/10. Subsequently, MD-C had been granted privileges for orthopedics under the category of courtesy staff membership for the privilege time period of 2/4/10, through 1/31/12; and 2/1/16, through 1/31/18. The privileges granted were subject to all the terms and conditions of the medical staff bylaws, rules and regulations, and CAH policies.
On 6/8/16, at 11:30 a.m. chief operating officer (COO) confirmed the CAH had an agreement with CIMRO Quality Healthcare Solutions (an outside peer review company). However, the COO stated she was unaware of any cases which had been sent to CIMRO in approximately the 8 ½ years the COO had been at the CAH.
On 6/9/16, at 8:37 a.m. the quality director (QD) confirmed peer review cases had never been sent out to CIMRO. The QD stated the CAH conducted their own internal peer review. The QD stated according to CAH policy, once a quarter each provider had three of their cases reviewed. This review was conducted by random selection or if there happened to have been a complaint on a case, that case would be included in the peer review process. The QD shared the Peer Review forms which were used to track the peer review process when cases were reviewed. The QD confirmed the CAH lacked a peer review form for surgical care services. The QD stated the CAH had eight family practice physicians on staff and they conducted peer reviews on each other. If there was a concern the chief of staff and the vice president of medical affairs (VPMA) would review the case. When further review was needed the case would be referred to the medical executive committee. The QD confirmed MD-B was the only active surgeon on staff. However, the CAH had another surgeon who occasionally filled in for MD-B. The QD stated the other surgeon would then review MD-B's cases. The QD confirmed MD-C was the only orthopedic surgeon on staff. The QD verified none of MD-C's cases had been reviewed through the peer review process since MD-C had been granted privileges in 2009. The QD stated MD-C's cases had not been sent out to CIMRO for peer review.
On 6/9/16, at 10:41 a.m. the QD stated MD-B had not had any cases reviewed through the peer review process since granted privileges on 1/15/15. In addition, none of MD-B's cases had been sent out to CIMRO for peer review. The QD stated MD-B had performed the majority of general surgery and endoscopy procedures which numbered:
- Fiscal year 2015 (January thru September) = 330 cases
- Fiscal year 2016 to date (October thru September) = 299 cases
The QD also stated MD-C had performed the below number of orthopedic cases over the past two and a half years:
- Fiscal year 2014 = 111 cases
- Fiscal year 2015 = 144 cases
- Fiscal year 2016 to date = 79 cases
On 6/9/16, at 11:11 a.m. the COO stated it was the CAH's expectation that the medical staff bylaws, rules and regulations, and CAH policy be followed with regard to the peer review process for all credentialed providers. The COO confirmed MD-B and MD-C should have had peer reviewed conducted as directed by CAH policy.
On 6/9/16, at 2:00 p.m. the VPMA verified MD-B and MD-C were currently practicing at the CAH. The VPMA stated the CAH understood they needed to improve with their peer review process.
A Peer Review policy dated 9/15, indicated for surgical services, three random charts from each provider would be reviewed utilizing the hospital peer review form. The review would be assigned to a provider which had not been involved with the case. The data would be summarized and flagged for the medical executive committee review if needed. The flagged charts would be brought to the medical executive committee and reviewed. Action plans would be created when necessary.
The CIMRO contract dated 12/15/09, with no termination dated noted, indicated the agreement between CIMRO and the CAH was for review services.
Bylaws of the Medical Staff, last revised 2008, indicated active and courtesy staff would be responsible for participation in the review and evaluation of patient care, utilization review, quality improvement and other monitoring activities. In addition under article IV, section B. 2 - functions and responsibilities of the Executive Committee included:
- Effectively implement the medical staff's responsibility for the CAH's quality assessment plan as it related to medical staff functions
- Review and evaluate qualifications of each applicant for initial appointment, reappointment and modification of appointment and for clinical privileges. Information from the quality, risk and utilization management processes would be taken into account during the reappointment process
- Review the overall practice of medicine at the CAH
Policy on Appointment, Reappointment, and Clinical Privileges of the Medical Staff, last revised 2008, indicated in Article III - ACTIONS AFFECTING MEDICAL STAFF APPOINTMENTS; Part A - PROCEDURE FOR REAPPOINTMENT; Section 2 - Factors to be considered for reappointment included:
- Ethical behavior, clinical competence and clinical judgement in the treatment of patients
- Capacity to satisfactorily treat patients as indicated by the results of the CAH's quality management and improvement activities, risk management and utilization review activities or other reasonable indicators of continued qualifications

Based on interview and document review, the critical access hospital (CAH) failed to ensure notification to the organ procurement organization (OPO) was completed in a timely manner for 1 of 3 patients (P22) who died at the facility. In addition, the CAH failed to integrate the organ, tissue and eye donation program into the facility wide quality program.
Findings include:
TIMELINESS OF NOTIFICATION OF DEATH TO THE OPO:
P22 was admitted to the CAH's emergency department on 9/25/15, for post cardiac arrest. Resuscitation efforts were unsuccessful and P22 was pronounced dead at 11:33 a.m.
P22's Death Record dated 9/25/16, indicated P22 had died at 11:33 a.m. and the OPO had been contacted at 1:50 p.m. (2 hours and 17 minutes post death).
On 6/8/16, at 3:30 p.m. director of nursing (DON) and clinical quality specialist (CQS) stated according to CAH policy and agreement with OPO all deaths should be called into the OPO within one hour of a patient's death. The DON and CQS confirmed P22's notification of death to the OPO had been greater than one hour.
The Amendment to the Organ Recovery Agreement Regarding Updated Regulatory Requirements between the OPO and the CAH dated 11/21/05, defined "timely notification" as within one hour of imminent death.
Organ and Tissue Donation policy dated 11/15, directed staff to refer all deaths to the OPO within one hour. This included when brain death was imminent and after cardiac death.
OPO INTEGRATED INTO CAH QUALITY PROGRAM:
On 6/8/16, at 10:05 a.m. quality manager (QM) verified the organ, tissue and eye donation program was not integrated into the CAH's quality program. The QM stated to his knowledge, OPO information had never been reported to the CAH's quality committee.
The Quality Management Program policy dated 9/15, indicated that ongoing monitoring and evaluation of indicators may be from a single service area or may cross organizational lines by a regulatory body or ones identified as critical to monitor to ensure patient safety, accuracy of process, and sustained improvement. The quality committee met on a quarterly basis.